Association of Copy Number Variations in the SMN Genes With Acute Kidney Injury After Heart Surgery

• Conditions: Acute Kidney Injury

• Registration Number: NCT04317196
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

This prospective cohort study aims to explore the susceptibility to acute kidney injury after heart surgery in SMN1+/- genotype population. This study also aims to analysis the effect of SMN1+/- genotype on postoperative AKI and the development of chronic kidney disease, as well as dose-compensating effect of different copy number of SMN2 gene on SMN1 +/- genotype.

Detailed Description

This prospective cohort study aims to explore the susceptibility to acute kidney injury after heart surgery in SMN1+/- genotype population. Real-time PCR is used to detect copy number variations in the peripheral blood SMN gene on 1206 patients with heart surgery. This study also aims to analysis the effect of SMN1+/- genotype on postoperative AKI and the development of chronic kidney disease, as well as dose-compensating effect of different copy number of SMN2 gene on SMN1 +/- genotype.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-23
• Study Start: 2020-04-01
• Last Update Submitted: 2020-05-09
• Last Update Posted: 2020-05-12
• Primary Completion: 2021-12-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1206

Inclusion Criteria

• Age: Children (1 month -17 years old) and adults (18-80 years old);
• Sex: All;
• Those who will receive selective cardiac surgery with cardiopulmonary bypass;
• Those who signed the informed consent.

Exclusion Criteria

• Those with glomerular filtration rate: eGFR<15ml/min/1.73m2, and those who have received the renal replacement therapy before surgery;
• Those who have received nephrectomy and kidney transplantation;
• Those who have suffered from AKI before;
• Those with incomplete medical history or clinical data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with occurrence of acute kidney injury (AKI) after cardiac surgery	48 hours	The definition of the occurrence of acute kidney injury is according to the acute kidney injury (AKI) definition and staging criteria released by Kidney Disease: Improving Global Outcomes (KDIGO) in the year 2012

Secondary Outcome Measures

Name	Time	Method
Number of participants with occurrence of acute kidney disease (AKD) after cardiac surgery	3 months	The definition of the occurrence of acute kidney disease is according to the acute kidney disease (AKD) definition criteria released by Kidney Disease: Improving Global Outcomes (KDIGO) in the year 2012
Glomerular Filtration Rate(GFR)	90 days	Glomerular filtration rate (GFR) is defined as the volume of plasma that is filtered by the glomeruli per unit of time, and is usually measured by estimating the rate of clearance of a substance from the plasma.

Trial Locations

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China